ICU Medical recalls oncology kits with potential leaks during chemotherapy that could interrupt treatment and expose patients to hazardous substances. Affected kits include specific models and lots; contact for remedy.
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
ICU Medical is recalling certain oncology kits that may leak during chemotherapy. If leaks occur during treatment, patients might get less medication than intended, and hazardous substances could be exposed to them or caregivers.
The oncology sets may leak during chemotherapy setup or therapy, potentially interrupting treatment. If leaks happen during therapy, patients might receive less medication than intended. Exposure to hazardous substances is also possible.
Patients receiving chemotherapy and caregivers handling the kits are most at risk. The recall affects specific models and production lots.
Check for the model name 'Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port' and lots 13919794, 14134777, or 14196319.
Inspect the kit for leaks during setup or therapy; if leaks occur, stop treatment immediately.
Yes, leaks during therapy could cause less medication to be delivered and expose patients to hazardous substances.
Check for the model name 'Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port' and lots 13919794, 14134777, or 14196319.
Inspect for leaks during setup or therapy; if leaks occur, stop treatment immediately.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2210-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2210-2026 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
